- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01661075
Quantification of Balance in Acutely Concussed Athletes
Quantification of Balance in Acutely Concussed Athletes, Implications for Return to Play Determination
The purpose of this pilot project is to determine whether using inertial sensors placed on the waist during routine clinical balance testing (i.e. Balance Error Scoring System) (BESS), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators are also trying to observe if the sensors can be used to detect balance recovery after a mTBI.
The investigators hypothesis is that collegiate atheltes with mTBI injury will have different recovery periods between their cognitive testing(IMPACT) and their balance measures.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
The purpose of this pilot project is to determine whether using inertial sensors (ipod like device) placed on the waist during routine clinical balance testing (i.e. Balance Error Scoring System (BESS), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators are also trying to observe if the sensors can be used to detect balance recovery after a mTBI.
The participants will be recruited through the local university's athletic department.
The participants will undergo balance tests from the BESS test while wearing a sensor around their waist.The BESS consists of different balance tests; such as balancing on one leg and tandem standing. The participants will also answer questionnaires about their daily lives and cognitive tests. If the participant has had a mTBI they will complete questionnaires about symptoms from their injury and may perform an additional IMPACT test which is a computerized cognitive tests used by coaches, athletic trainers and managing physicians.
Along with the clinical balance tests and questionnaires, the project will use a small sensor placed on the waist to detect sway during quiet stance. An automatic analysis will occur which will provide us with immediate feedback on how stable the participant is during testing.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Oregon
-
Portland, Oregon, Verenigde Staten, 97239
- Oregon Health and Science University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Collegiate athlete
Exclusion Criteria:
- Not a current collegiate athlete,
- recent orthopedic surgery
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
mTBI
These individuals will have had an mTBI during their respective collegiate athletic season.
|
|
healthy controls
Recruitment of healthy controls who have not suffered an mTBI for balancing testing.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Instrumented Modified Balance Error Scoring System
Tijdsspanne: 2 months
|
2 months
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Laurie A King, PhD, Oregon Health and Science University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 7419_2
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .